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Celyad Oncology Presents Data Update from Phase 1 alloSHRINK Trial for CYAD-101 in mCRC at ASCO-GI Symposium

Median overall survival and median progression free survival from the dose-escalation segment of the trial were 10.6 months and 3.9 months, respectively



Tumor burden decrease observed in eight of 15 refractory unresectable mCRC patients, including six of nine patients at the highest dose level of 1x109 cells per infusion



Emergence of new T cell clones in the peripheral blood T cell repertoire four months after therapy was observed in patients analyzed from the highest dose level who experienced either a confirmed partial response or stable disease suggesting that modulation of the endogenous immune response may be an important mechanism of action of CYADa??101 in mCRC patients



Preliminary data from the ongoing expansion cohort of the Phase 1 alloSHRINK expected in the first half of 2021

MONT-SAINT-GUIBERT, Belgium, Jan. 18, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced updates from the A Phase 1 alloSHRINK trial evaluating CYAD-101, the Companya??s allogeneic NKG2D-receptor and T cell receptor (TCR) inhibitory molecule (TIM)-based, non-gene edited CAR T candidate administered concurrently with FOLFOX chemotherapy for the treatment of refractory metastatic colorectal cancer (mCRC), presented at the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium (ASCO-GI), held virtually from January 15-17, 2021."We continue to build on the promise of CYAD-101, a highly differentiated cell therapy investigational candidate which has delivered preliminary evidence of clinical benefit for an allogeneic CAR T in solid tumors," said Filippo Petti, Chief Executive Officer of Celyad Oncology. "At ASCO-GI, we highlighted the encouraging median progression free-survival data from alloSHRINK which complements the previously reported tolerability, objective response rate for CYAD-101 in patients with mCRC. Moreover, translational data from the trial suggests that immune modulation underpins the clinical responses observed in the alloSHRINK trial and supports further development of CYAD-101 with therapies with complementary mechanisms of action including checkpoint inhibitors. Wea??re excited about the next steps for the CYAD-101 program for the treatment of advanced colorectal cancer and we look forward to future updates from the alloSHRINK trial as well as initiating the upcoming Phase 1b KEYNOTE-B79 trial.a??Phase 1 alloSHRINK Trial UpdateBackground

A total of 15 patients with relapsed/refractory mCRC who progressed after previous treatment with oxaliplatin-based or irinotecan-based chemotherapies were treated in the dose-escalation segment of the alloSHRINK trial evaluating three dose levels of CYAD-101 (1x108, 3x108, 1x109 cells per infusion) administered concurrently with FOLFOX as preconditioning chemotherapy. The number of prior therapies received by patients enrolled in the trial ranged from one to six with a mean of three.



Previously reported data for primary and secondary safety and clinical activity endpoints include:
- Two patients achieved a confirmed partial response (PR) according to RECIST 1.1 criteria, including one patient with a KRAS-mutation
- Nine patients achieved stable disease (SD), with seven patients demonstrating disease stabilization lasting more than or equal to three months of duration
- Median progression free survival (mPFS) for the dose-escalation segment of the trial was 3.9 months
- No clinical evidence of Graft-versus-Host Disease (GvHD)
- Treatment was observed to be well-tolerated with no treatment-related adverse events greater than Grade 3
- The recommended dose of 1x109 CYAD-101 cells per infusion will be further evaluated in the expansion cohort of the alloSHRINK trial concurrently with FOLFIRI chemotherapy

Updated Clinical and Translational Data
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